ParturientsNCT00811707
Epidural Sonoanatomy Between Parturient and Non-Pregnant
An observational study of Parturients, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The failure in indwelling epidural catheter for a parturient might cause an anesthetic difficulty. Furthermore, no one can predict the accuracy of needle placement prior to skin puncture with any of landmark-based technique. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parturients
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2008to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: from Kaohsiung Medical University Hospiral ward parturients
Who may be able to join
- parturients scheduled to receive lumbar epidurals for elective cesaeran delivery labor analgesia
Who cannot join
- Pregancy induced hypertension gestational Diabetes patients who refuse
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Hospital
Kaohsiung City, 807
Koung-Shing Chu, Master, 886-7-3121101 ext. 7035, cks0708@ms.kmuh.org.tw
About this study
Official title: To Compare Epidural Sonoanatomy Between Parturient and Non-Pregnant Young Female in Chinese Population
The failure in indwelling epidural catheter for a parturient might cause an anesthetic difficulty. Furthermore, no one can predict the accuracy of needle placement prior to skin puncture with any of landmark-based technique. This may result in multiple trying attempts at needle puncture, pain and discomforts of patients and poor patient satisfaction. The aim of this study was to explore the difference of epidural space between parturient and non-pregnant women by assessing ultrasound image.
Read the detailed description
We will enroll 30 non-pregnant female volunteers and 30 parturients(ASA I-III) underwent epidural blocks. A low frequency ultrasound (2-5 MHz) with a curved array transducer is used to obtain spinal sonography for each subject. The paramedian axis was used to obtain optimal ultrasound image for spinal sonography. Outcome was evaluated by the diameter and depth of epidural space at three lumbar interspaces. Paired T-test was carried out to evaluate the statistical significance of epidual diameter and depth.
- Conditions
- Parturients
- Keywords
- ultrasound image, epidural space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1: volunteers | non-pregnant female | |
| 2: parturients | parturients was scheduled to receive lumbar epidurals for elective cesaeran delivery labor analgesia |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturientsStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811707
- Sponsor's protocol ID
- KMUH-IRB-970112
- Status last verified
- Aug 2008
- First submitted
- 18 Dec 2008
- Last updated
- 19 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Epidural Sonoanatomy Between Parturient and Non-Pregnant Young Female in Chinese Population
- ClinicalTrials.gov ID
- NCT00811707
- Acronym / sponsor ID
- KMUH-IRB-970112
- Conditions
- Parturients
- Keywords
- ultrasound image, epidural space
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The failure in indwelling epidural catheter for a parturient might cause an anesthetic difficulty. Furthermore, no one can predict the accuracy of needle placement prior to skin puncture with any of landmark-based technique. This may result in multiple trying attempts at needle puncture, pain and discomforts of patients and poor patient satisfaction. The aim of this study was to explore the difference of epidural space between parturient and non-pregnant women by assessing ultrasound image.
Detailed description
We will enroll 30 non-pregnant female volunteers and 30 parturients(ASA I-III) underwent epidural blocks. A low frequency ultrasound (2-5 MHz) with a curved array transducer is used to obtain spinal sonography for each subject. The paramedian axis was used to obtain optimal ultrasound image for spinal sonography. Outcome was evaluated by the diameter and depth of epidural space at three lumbar interspaces. Paired T-test was carried out to evaluate the statistical significance of epidual diameter and depth.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: volunteers | – | –non-pregnant female |
| 2: parturients | – | –parturients was scheduled to receive lumbar epidurals for elective cesaeran delivery labor analgesia |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- from Kaohsiung Medical University Hospiral ward parturients
Key inclusion criteria (1 listed)
- parturients scheduled to receive lumbar epidurals for elective cesaeran delivery labor analgesia
Key exclusion criteria (1 listed)
- Pregancy induced hypertension gestational Diabetes patients who refuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2008.
Related trials for Parturients
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
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Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
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Wearable Ultrasound Patch in Parturients
Pregnancy - Labor Monitoring, Labor and Childbirth
RecruitingPhase 4
Routine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia
Intraoperative Nausea-retching-vomiting Episodes, Spinal Aneshtesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parturients, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Koung-Shing Chu, Master (886-7-3121101 ext. 7035, cks0708@ms.kmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2008.